Drug Compendia

Assistance Listings Prescription Digital Therapeutic Product in Drug Compendia

IndustryDrug Compendia
ProblemA Prescription Digital Therapeutics (PDT) company was launching their first PDT and sought assistance from PHSL with listing their product within the drug pricing compendia, which was necessary for the product to be e-prescribed by HCPs, adjudicated to payers, and dispensed by their pharmacy partner.
PHSL SolutionPHSL provided education surrounding the drug pricing compendia, provided guidance on obtaining a GTIN through GS1, and assisted with GTIN-14 reformatting needed for listing their product in the compendia. Prior to launch, PHSL reviewed product information on the new PDT and shared insights on currently available Digital Therapeutic (DTx) products in the compendia to assist in a compendia submission strategy.
ResultsThe PDT company gained insight into the pricing compendia submission process, and their PDT product was successfully listed in the drug pricing compendia.

Correcting Compendia for Better Differentiation of Products

IndustryDrug Compendia
ProblemA brand manufacturer’s newer product version was being mistaken for a similar but not as easy-to-use precursor product, due to a lack of differentiation in the product’s name in the drug compendia. This caused prescribers to erroneously select the similar precursor product in the electronic health record when intending to select the client’s newer product. Not only was this disadvantageous to the client, but, most importantly, it was disadvantageous to patients who may have been educated on the client’s newer product only to be given a different and more difficult-to-use product.
PHSL SolutionPHSL reviewed the listings of the two products in the drug compendia to understand why prescribers were selecting the incorrect product when attempting to prescribe the client’s newer product in the electronic health record. PHSL identified the issue regarding the product’s name in certain drug databases. At the client’s direction, PHSL then composed a letter to the affected drug compendia requesting a more accurate listing of the product’s name to better differentiate the precursor and newer products and alleviate any confusion at the point of prescribing.
ResultsThe request for a change in the product’s name to more precisely reflect both the precursor and newer products was accepted. This helps to facilitate accurate prescriber selection in the electronic health record, which will result in patients receiving the correct medication.

Therapeutic Classification in Drug Compendia at Product Launch

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer had a forthcoming product with the same general mechanism of action as current on-market agents. However, the product differed in its indication and expected usage. The client was seeking assistance in differentiating their product from competitors within the drug pricing compendia, in the hopes of being favorably viewed by payers.
PHSL SolutionPHSL reviewed the draft Prescribing Information of the manufacturer’s forthcoming product. PHSL then analyzed and identified current therapeutic classifications available in the leading drug pricing compendia databases and worked with the manufacturer to proactively request a unique categorization for the drug.
ResultsThe manufacturer was able to gain a unique Enhanced Therapeutic Classification (ETC) category in FDB, differentiating them from their competitors.

Drug Compendia Assistance for OTC Products

IndustryDrug Compendia
ProblemThe manufacturer of several over the counter (OTC) compounding vehicle agents requested assistance in understanding how their products were being grouped with competitor products. Based on the product groupings, the manufacturer was experiencing issues with product substitution at the wholesaler level, thus resulting in a loss in sales.
PHSL SolutionPHSL reviewed the product listings in the leading drug pricing compendia to understand how product attributes of the client’s product and competitor products were impacting ordering through wholesalers. PHSL discussed strategies and worked with the client to finalize an approach to use with the drug compendia providers. PHSL worked with the client to draft and submit drug compendia change forms to request attribute changes for the affected products.
ResultsA compendia change request was successful, and the client’s product was able to be reclassified in First Databank, resulting in a change in the GCN, thus helping to mitigate substitution concerns at the wholesaler level.

Listing a BLA-Approved Product Competing with Devices in Drug Compendia

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer was launching a new product approved through a BLA that would compete with similar products that are approved as devices. The manufacturer sought to better understand how these competitor products were categorized and optimize how their BLA-approved product would be listed in the pricing and clinical compendia.
PHSL SolutionPHSL examined competitor devices in four different drug compendia. Analysis focused on areas that may differentiate a BLA-approved product from a device. PHSL drafted compendia submission forms to ensure proper and complete documentation related to product naming, description, and pricing was communicated with each drug compendia.
ResultsPHSL recommended communications to drug compendia that ensured the manufacturer’s product was appropriately listed and well-positioned in relation to its device competitors.

Post-Merger Product Review in Drug Compendia

IndustryDrug Compendia
ProblemTwo pharmaceutical manufacturers who recently merged sought a review of their products in the drug compendia following their merger to ensure no inconsistencies existed in the compendia.
PHSL SolutionUsing their expertise in the compendia, PHSI performed an independent review and examined four different drug compendia for any inconsistencies with the client’s products regarding packaging, pricing, and the active status of the products.
ResultsBy reviewing the compendia, PHSI was able to provide insight into selected products with discrepancies and recommended communications and corrections to the various drug compendia. For the remaining products, the client was assured that there were no identifiable differences between the drug product label and the compendia listing. This enabled the client to prevent any issues with prescribing, product selection, and reimbursement for their drug products.

Assistance Listing Devices in the Drug Compendia

IndustryDrug Compendia
ProblemA device manufacturer was launching an updated and enhanced version of their diabetes device. The new product was scheduled to have a different name, but the device manufacturer wanted to ensure that the different versions were distinguishable to prescribers in their e-prescribing systems. The device manufacturer was also seeking information on how their product would appear when compared to competitors.
PHSL SolutionPHSI reviewed the 510(k) approval letter, device user guide, and analogue device listings within the major drug compendia providers. Using the information gathered, PHSI hypothesized which products would share the same category with the newly-launched device. PHSI then drafted compendia submission forms for the device manufacturer and guided them through the compendia submission process.
ResultsThe device manufacturer’s product was successfully listed in all of the drug compendia. It was listed with unique naming that differentiated it from previous versions of the device, aiding in accurate prescribing and dispensing.

Monitoring Drug Compendia Listings of Competition

IndustryDrug Compendia
ProblemA generic pharmaceutical manufacturer required additional insights on products in their pipeline. The focus was their competitor listings in the drug compendia to understand market changes so they could continually update financial projections and determine profitable product launches.
PHSL SolutionPHSI created alerts in the drug compendia for the select products to provide monitoring of new launches, labeler changes, and NDC inactivations. Alerts are reviewed daily and an assessment of the impact of the changes is sent to the manufacturer.
ResultsThe pharmaceutical manufacturer used these to refine their product launch decisions and determine viable drug products to commercialize.

Manufacturer Sought Insight on Inner-Pack NDC Compendia Listing

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer faced lost sales with both prescribers and pharmacies based upon their inner-pack and outer-pack national drug code (NDC) product listing in drug compendia. The client desired to identify and align classifications of their product listing in the drug compendia to resolve issues on various EHR and pharmacy dispensing software systems impacting the prescribing, distribution, and dispensing process.
PHSL SolutionPHSI analyzed the drug compendia NDC package file definitions for inner-pack and outer-pack NDCs. PHSI prepared actionable next steps for the manufacturer at both the wholesaler and pharmacy level to clarify the client’s product listing. PHSI prepared a concise summary clarifying the use of outer-pack NDCs for ordering and dispensing as well as the purpose for the inner-pack NDC for patient safety. PHSI provided actionable recommendations for drug compendia modifications and clarification steps to communicate with suppliers, EHR system companies, and community pharmacies to ensure proper prescribing and dispensing of their product.
ResultsPHSI insight addressed the problems the client faced and removed potential barriers to improve efficiency in product prescribing and distribution process. The client understood NDC package drug characteristics and impact on different channel stakeholders from the product’s listing in drug compendia. The manufacturer implemented PHSI’s recommendations at the pharmacy level, and the dispensing issues previously seen at pharmacies were greatly reduced.

Drug Compendia Product Submission

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer with a new product lacked experience working with drug compendia and desired to have their drug listed properly before launch. The client had drug compendia challenges with previous launches and wanted to minimize issues with their new product.
PHSL SolutionPHSI prepared and led an onsite training program for the brand team and management from several operational areas including finance, regulatory, and sales. The training provided foundational knowledge about the role and importance of drug compendia, as they are used by prescribers with EMR systems, pharmacies for product selection, and payers for claims adjudication. PHSI assisted the client with drug compendia form completion and submission to Medi-Span, First Databank, Gold Standard, Cerner Multum, and Red Book. Finally, PHSI monitored these compendia publications to ensure there were no inconsistencies with how the new product was listed in the various compendia.
ResultsClient was better prepared to launch their new product and lowered their risk of drug compendia issues impacting prescribing and distribution. They integrated the compendia activities into their product launch plans and factored in the time for the new drug information to reach pharmacies, payers, and especially EHR systems. This ensured the product was available to e-prescribe almost immediately post product launch. The compendia process has become a best practice and will be included in launch planning for all new future products.